Preoperative romiplostim to raise platelets before cardiac surgery

Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery. A Phase 3, Multicenter Randomized Double-blinded Controlled Against Placebo Study.

This test tries whether a short course of romiplostim can raise platelet counts so adults with low platelets can safely have cardiac surgery with cardiopulmonary bypass.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nantes University Hospital (Academic / other)
• Drugs / interventions: Rituximab, prednisone
• Locations: 8 sites (Angers and 7 other locations)
• Trial ID: NCT07278661 on ClinicalTrials.gov

What this trial studies

This phase 2 interventional trial gives adults with preoperative thrombocytopenia either romiplostim or placebo between 10 and 14 days before planned cardiac surgery with cardiopulmonary bypass. Participants will be hospitalized within 15 days of the first dose and monitored clinically and with laboratory tests for at least 10 days after surgery to detect and manage adverse events. Surgeries must use an intraoperative blood recovery system (centrifugation/Cell Saver type) and patients are expected to require antiplatelet or anticoagulant therapy for at least one month postoperatively. The study aims to determine whether preoperative romiplostim can increase platelet counts enough to allow safer and timely cardiac operations in this patient group.

Who should consider this trial

Good fit: Adults scheduled for cardiac surgery with cardiopulmonary bypass who have preoperative platelet counts under 150,000/mm3 and can receive the first injection 10–14 days before surgery are ideal candidates.

Not a fit: Patients who cannot receive the first injection within the required 10–14 day window, those having cardiac procedures without cardiopulmonary bypass, or those planned to use incompatible intraoperative blood recovery systems are unlikely to benefit.

Why it matters

Potential benefit: If successful, more patients with low platelets could undergo lifesaving cardiac surgery without delay by increasing platelet counts before the operation.

How similar studies have performed: Romiplostim has demonstrated efficacy and good tolerance in other thrombocytopenic conditions, but its specific preoperative use in cardiac surgery is relatively untested.

Eligibility criteria

Inclusion Criteria:

* Adult patients with no upper age limit,
* Scheduled cardiac surgery with cardiopulmonary bypass,
* Patients with preoperative thrombocytopenia strictly \<150,000/mm3
* Surgery performed with a blood recovery system using centrifugation (Cell Saver type) or equivalent,
* Feasibility of a first injection (Romiplostim or Placebo) between D-14 and D-10 before surgery,
* Surgery requiring the administration of antiplatelet and/or anticoagulant therapy for a minimum of 1 month postoperatively.

Exclusion Criteria:

* Inability to administer the first injection of Romiplostim or Placebo within 10 days prior to surgery,
* Cardiac surgery without cardiopulmonary bypass,
* Coronary artery bypass grafting due to one or more significant coronary stenoses,
* Tangential filtration blood recovery system (i-SEP SAME® type) planned for intraoperative use or absence of intraoperative blood recovery system due to investigator choice or availability issues,
* Planned use of aprotinin as an antifibrinolytic agent during surgery,
* Patient with contraindication to discontinuation of all antiplatelet therapy before surgery (with discontinuation at least 3 days before surgery for acetylsalicylic acid and at least 5 days before surgery for clopidogrel/ticagrelor),
* Hereditary or acquired thrombophilia with or without a history of thrombosis,
* History of ischemic or hemorrhagic stroke,
* History of phlebitis, pulmonary embolism, or portal vein thrombosis,
* History of heart attack with stent placement less than one year ago,
* Current limb immobilization (e.g., plaster cast for ankle fracture) or inability to walk independently due to limited mobility (e.g., paralysis),
* Current immobilization of a limb (e.g., plaster cast for ankle fracture) or inability to walk independently due to motor limitation (e.g., complete paralysis of a limb) or medical contraindication (e.g., strict bed rest required),
* Myelogram indicating malignant hematological disease or blast cells strictly greater than 5%,
* Malignant diseases with last follow-up indicating disease progression,
* Severe chronic liver disease with a CHILD-PUGH score \> 6 (measured without decompensation),
* Treatment with thrombopoietin receptor agonist received within 3 months prior to inclusion,
* Treatment with JAK2 inhibitor currently underway or within the last month,
* Treatment with Rituximab within the last 7.5 months or intravenous immunoglobulin within the last 40 days,
* Ongoing treatment with corticosteroids at doses equal to or greater than 20mg of hydrocortisone, 5mg of prednisone/or prednisolone, 4mg of methylprednisone, or 0.75mg of dexamethasone,
* Known hemophilia,
* Hypersensitivity to romiplostim or any of its excipients, or to proteins derived from E. coli,
* Context of hyperchloremia, hypernatremia, or major water and salt retention with anasarca refractory to medical treatment,
* Pregnant women or women of childbearing age who are not using effective contraception,
* Currently using combined oral contraceptive pills or oral hormone replacement therapy containing estrogen,
* Breastfeeding women,
* Minors,
* Adults under guardianship, curatorship, or judicial protection,
* Patients who do not speak French,
* Patients without Social Security coverage.

Where this trial is running

Angers and 7 other locations

• CHU d'Angers — Angers, France (Not_yet_recruiting)
• CHU de Bordeaux — Bordeaux, France (Not_yet_recruiting)
• CHU de Brest — Brest, France (Not_yet_recruiting)
• CHU de Dijon — Dijon, France (Not_yet_recruiting)
• CHU de Nantes — Nantes, France (Recruiting)
• Hôpital Bichat (AP-HP) — Paris, France (Not_yet_recruiting)
• CHU de Rennes — Rennes, France (Not_yet_recruiting)
• CHU de Strasbourg — Strasbourg, France (Not_yet_recruiting)

Study contacts

• Study coordinator: Jean- Christophe RIGAL

Conditions Chirurgical Intervention; Thrombocytopaenia; Thrombocytopenia; Cardiac Surgery; Growth Factor; Patient Blood Management